MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE STABILIZATION FISHMOUTH DRGDE *EA; SURGICAL HAND DRILL

Catalog Number	213817
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure the customer's lupine fishmouth drill guide and lupine drill bit created metal shavings in the patient's joint space.The sales rep stated that the metal shavings were removed with the shaver and that no debris was left in the patient.The procedure was completed with the devices as the issue occurred towards the end of the case.There was no patient harm or surgical delay to the case.The sales rep could not provide lot numbers for the devices but stated that the devices are approximately five years old and have seen heavy use in the field.The devices will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: (d4): lot and expiration date.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: the device was received for evaluation.It was observed that the inner surface of the drill guide had striations on it indicating that drill would loosely fit inside it.This could be a probable cause of the metal particles.This complaint can be confirmed.The drill guide is over eleven years old and repeated sterilization cycles could cause the guide to lose its straightness which would cause the drill to loosen metal particles on the inner surface.Other than this possibility, we cannot discern a root cause for this failure.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A manufacturing record evaluation was performed for the finished device lot number on 11-4-2019, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history a manufacturing record evaluation was performed for the finished device lot number on 11-4-2019, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9126756
• Report Number: 1221934-2019-58636
• Device Sequence Number: 2374068
• Product Code: FZX
• UDI-Device Identifier: 10886705003280
• UDI-Public: 10886705003280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 213817
• Device Lot Number: 08H1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 11/05/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/29/2019; 11/07/2019
• Patient Sequence Number: 1